- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03419351
Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
Self evaluating tools based on smartphone devices are public available on the market for each person. The tools are used to estimate the existing refractive error for each eye of a patient. Hereafter, e.g. ordering glasses via internet could be the next step for this persons.
The daily routine within an eye hospital shows, that estimation of the refractive error is a difficult and time consuming procedure.
The study compares the results of the measured refractive error using a smartphone based tool with the results of conventional measurement methods.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
BW
-
Tuebingen, BW, Germany, 72076
- Recruiting
- University Eye Hospital
-
Contact:
- Martin A Leitritz, M.D.
- Phone Number: +49 (0) 7071-29-88088
- Email: martin.leitritz@med.uni-tuebingen.de
-
Principal Investigator:
- Martin A Leitritz, M.D.
-
Sub-Investigator:
- Sebastian Mueller, M.D.
-
Principal Investigator:
- Markus Schulze-Schwering, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- existing refractive error
- using glasses or contac lenses
Exclusion Criteria:
- opacities (visus limitating) of cornea, lens or vitreous
- known ocular pathologies except refractive error
- epilepsia
- irregular corneal topography
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Main group
Main study group including all individuals that underwent the study procedures
|
Smartphone based measurement of refractive error and visual acuity testing using these measurements.
Autorefractor based measurement of refractive error and visual acuity testing using these measurements.
Individual, human measurement of refractive error and visual acuity testing using these measurements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Refractive Error
Time Frame: 6 month
|
Comparison of refractive error measurements between methods
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: 6 month
|
Visual acuity of persons using based on different methods.
|
6 month
|
Personal evaluation of measuring accuracy (Questionnaire)
Time Frame: 6 month
|
Would persons be willing to order glasses by using only self-test-results?
|
6 month
|
Time consumption
Time Frame: 6 month
|
Comparison of needed time to reach self-test refraction error results and conservative-test results.
|
6 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- smart-glass
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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